Safety and Efficacy Study of the Draeger Babylog VN500 Device in HFOV Mode in VLBW Neonates

Status unconfirmed · Not applicable

Conditions studied: Respiratory Distress Syndrome In Premature Infants

In brief

The purpose of this study is to determine the safety and effectiveness of the Babylog VN500 in high frequency oscillatory ventilation (HFOV) mode as a method for treating very low birth weight (VLBW) neonates requiring invasive respiratory support in the treatment of respiratory distress.

Key facts

Study ID

NCT02445040

Run by

Draeger Medical Systems, Inc.

People needed

225

Starts

2015-07-01

Expected to finish

2020-09-01

Last updated by the study team

2019-09-19

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Gestational Age between 23 to 30 weeks; within first 4 days of life
• very low birth weight between 400 g and 1200 g, inclusive
• 5-minute Apgar score >3
• documented respiratory distress requiring invasive respiratory Support
• A priori: primary intention for either HFOV or high-frequency jet ventilation OR Severity of Illness: mechanical ventilation with a fraction of inspired oxygen of ≥ 0.25% and a mean airway pressure of ≥ 7 cm H2O, more than 2 hours after an initial dose of surfactant required and clinical care team believes that treatment with HFOV is indicated
• anticipated availability of investigational device at the study center before screening for enrollment
• written informed consent to participate in the study provided by a parent or legal guardian

You may not qualify if…

• anticipation to require intubation and mechanical ventilation for less than 12 hours
• previous exposure to any mechanical ventilation for ≥ 96 hours before planned HFOV treatment
• obvious chromosomal or major congenital abnormalities involving the respiratory tract or upper airway
• known congenital heart disease, excluding Patent Ductus Arteriosus (PDA), ventricular-septal defect, or atrial-septal defect
• pre-existing air leak, including pneumothorax, pneumomediastinum, pneumopericardium, or extensive bilateral Pulmonary Interstitial Emphysema (PIE)
• severe metabolic acidosis with a base deficit of ≥ 15 before planned HFOV treatment
• severe hypotension (a mean blood pressure more than 2 standard deviations below the mean neonate's birth weight despite a total combined dose of dopamine, dobutamine, or both, of 20 µg(kg/min)
• moribund subject not expected to survive, or a subject in whom there is a decision to limit care
• currently receiving or previous treatment with inhaled nitric oxide
• currently receiving or previous treatment with corticosteroids specifically for BPD prevention
• evidence of severe sepsis (neutropenia, severe hypotension, shock)
• evidence of Nectrotising Enterocolitis (NEC), defined as Modified Bell's Stage II or greater
• documented Grade III/IV intraventricular hemorrhage
• current enrollment in another Investigational Device Exemption or Investigational New Drug clinical study where treatment, testing, or follow-up may interfere with the results

Where it is running

• Arkansas Children's Hospital — Little Rock, Arkansas, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Sharp Mary Birch Hospital for Women and Newborns — San Diego, California, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Children's Hospitals and Clinics of Minnesota — Minneapolis, Minnesota, United States
• St. Paul Children's Hospital — Saint Paul, Minnesota, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• New Hanover Regional Medical Center — Wilmington, North Carolina, United States
• Women & Infants Hospital of Rhode Island — Providence, Rhode Island, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States
• North Central Baptist Hospital — San Antonio, Texas, United States
• Intermountain Medical Center — Murray, Utah, United States
• University of Utah Health Science Center — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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